Randomised double-blind placebo controlled study to determine whether the use of selective digestive decontamination pastilles reduces radiation mucositis

ISRCTN ISRCTN67519330
DOI https://doi.org/10.1186/ISRCTN67519330
Secondary identifying numbers HN9
Submission date
01/07/2001
Registration date
01/07/2001
Last edited
02/02/2012
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr - -
Scientific

UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom

Study information

Study designRandomised double-blind placebo controlled study
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeNot Specified
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific title
Study objectivesNot provided at time of registration
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedHead and neck
Intervention1. Group A: Active SSD pastille (Polymyxin E 2 mg, Tobramycin 1.8 mg and Amphotericin B 10 mg). Treatment to start on the day radiotherapy begins, one pastille four times daily until radiation reactions have settled.
2. Group B: Placebo pastille four times daily. Treatment to start on the first day of radiotherapy until radiation reactions have settled.
Intervention typeOther
Primary outcome measureNot provided at time of registration
Secondary outcome measuresNot provided at time of registration
Overall study start date01/01/1999
Completion date31/12/2000

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexNot Specified
Target number of participantsNot provided at time of registration
Key inclusion criteria1. Patients with head and neck cancer receiving potentially curative doses of radiotherapy
2. Eligible patients may have squamous carcinoma, adenocarcinoma or salivary tumours arising in the oral cavity, nas -oro, or hypopharynx, larynx and paranasal sinuses
3. Stages T1-T4
4. No allergy to Polymyxin E, Tobramycin or Amphotericin B
5. No pre-existing oral or oropharyngeal infection
Key exclusion criteriaNot provided at time of registration
Date of first enrolment01/01/1999
Date of final enrolment31/12/2000

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

UKCCCR Register Co-ordinator
London
NW1 2DA
United Kingdom

Sponsor information

UK Co-ordinating Committee for Cancer Research (UKCCCR)
Government

MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom

ROR logo "ROR" https://ror.org/054225q67

Funders

Funder type

Not defined

Not available

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/07/1996 Yes No